510(k) Report

FDA applicant

Seabrook Medical Systems, Inc.

Cincinnati, OH12 decisions1984–19952 recalls

FDA records 12 decisions for Seabrook Medical Systems, Inc. (Cincinnati, OH) from 1984 to 1995: 12 510(k) clearances. Most are in product codes ILO (Pack, Hot Or Cold, Water Circulating) and DWJ (System, Thermal Regulating). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Seabrook Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seabrook Medical Systems, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Seabrook Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ILOPack, Hot Or Cold, Water Circulating6decisions
  • DWJSystem, Thermal Regulating5decisions
  • DWCController, Temperature, Cardiopulmonary Bypass1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K843146Micro-Temp Pumps & Micro-Temp PadsSeabrook Medical Systems, Inc. · 19841cites it
  • K881322Mini-Temp (TM)Seabrook Medical Systems, Inc. · 19881cites it
  • K902269Electri-Cool (TM) Liquid-Circulat. Thermal TherapySeabrook Medical Systems, Inc. · 19901cites it
  • K902756Tropi-CoolSeabrook Medical Systems, Inc. · 19901cites it

What has FDA decided for it lately?

  • K946196Tropicair Convective Waring SystemSeabrook Medical Systems, Inc. · 1995
  • K952086Tropicair Convective Warming BlanketsSeabrook Medical Systems, Inc. · 1995
  • K931203Cool-AidSeabrook Medical Systems, Inc. · 1994
  • K923104Tropic-AirSeabrook Medical Systems, Inc. · 1993
  • K914182Golden Thermal (R)Seabrook Medical Systems, Inc. · 1991
  • K902756Tropi-CoolSeabrook Medical Systems, Inc. · 1990
  • K902268Pedia-Temp (TM) Liquid-Circulating Hypo-Hypertherm.Seabrook Medical Systems, Inc. · 1990
  • K902269Electri-Cool (TM) Liquid-Circulat. Thermal TherapySeabrook Medical Systems, Inc. · 19901 recall

All 12 as Seabrook Medical Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K843146Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used…Jan 7, 2015Class II
  • K843146Micro-temp II heat therapy unit, model #747.Jan 18, 2005